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The Seventh Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum November 9, 2006 Washington, DC. . 3.06. Integrating Compliance with Business: Integrating Compliance Auditing & Monitoring with Internal Audit. Disclaimer.
Pharmaceutical Regulatory and Compliance Congress
and Best Practices Forum
November 9, 2006
The information presented and discussed represents the opinions of the authors/presenters and, although descriptive of general activities, they do not necessarily reflect the views of either Amgen or Deloitte & Touche LLP
As Executive Director of Corporate Audit for Amgen, Wayne Davey works with the General Auditor, senior company management, and the audit function staff to provide independent, objective assurance and consulting services designed to add value and improve the operations of Amgen. Upon joining Amgen in June 2004, he became the Project Leader for Amgen’s successful Sarbanes-Oxley compliance and certification efforts. He is currently assigned to lead all worldwide operational and compliance audits.
Prior to his current position at Amgen, Wayne was the CFO and VP of Business Operations at the Rockwell Scientific Company (RSC), a privately-held technology company with approximately $110 million in annual sales. Prior to his position at RSC, he served as Director of Corporate Accounting for Rockwell International and then later in a similar position at Hughes Electronics.
Wayne received a BS degree from the University of Arizona and an MBA degree from UCLA.
David Chandler is a Director of Corporate Compliance over the Outcomes and Analysis program at Amgen Inc. His responsibilities include the selection and deployment of a unified audit management system, analysis of audit data within and across audit organizations, and reporting on critical audit findings to executive management.
Prior to his current position he was the Manager of the Compliance and Regulatory program at 3M Pharmaceuticals where his responsibilities included monitoring and developing compliance programs for cGMP, GCP, GLP, HIPAA, Pharmacovigilance, PDMA, WLF, PhRMA Code of Conduct, OIG Guidance, Medical Education, State reporting requirements, and grant and consultant activities. Previous position included Manager of Toxicology at 3M Corporation, Director of the Hazardous Materials Program for the State of Oregon and Principle/Director of the Chemical and Risk Information System and Associate Professor at Oregon Health Sciences University.
David holds a Ph.D. in Pharmacology/Toxicology from the University of California, Davis, and an MBA from the University of St. Thomas.
Sheryl Vacca is the West Coast Practice Leader in the Life Sciences Regulatory Practice at Deloitte & Touche LLP. Sheryl is also the National Lead for Health Care Internal Audit for Deloitte. Sheryl has been in life science for 28 years and has a significant amount of experience in regulatory compliance, auditing and monitoring and dispute areas in life sciences. She has been involved with the development of compliance and operational controls, internal audit and has expertise in providing advice on regulatory compliance issues for life science focusing on internal control process, key risk areas in regulatory compliance, financial and compliance due diligence, operational design and litigation support including voluntary disclosures to enforcement agencies.
Sheryl is a nationally recognized speaker and has published on compliance related topics, including auditing and monitoring concepts, quality of care, compliance program elements and compliance program effectiveness. Ms. Vacca is a Past President and current Board Member of the Health Care Compliance Association. Ms. Vacca has her BSN and also holds a master’s degree in administration. She is also a member of the Editorial Board for the Journal of Health Care Compliance, published by Aspen Publishers.
Embedded Compliance Functions
All Amgen staff members and contractors
Research & Development
Healthcare & Competition
Manufacturing & Distribution
Key Compliance Obligations
AuditCorporate Audit has Responsibility for General and Financial Audits
Direct link To Senior Managementprovides
• Strategic DirectionforOperational Reviews
• Exposure&Development Opportunities
Direct link to Audit Committee provides
• Independencefor Financial Reviews
For Selected Compliance Audits Where Corporate Audit Will Be Conducting the Audit the Following Roles and Responsibilities Have Been Determined